ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31604 results sorted by trial registration date.
  • A randomised controlled trial of Eutectic Mixture of Lidocaine and Prilocaine (EMLA) cream as a primary dressing for painful chronic leg ulcers: A pilot study.

    The aims of this study will address the following hypotheses, that: The daily topical application of EMLA cream to the wound bed reduces pain levels for patients with a chronic leg ulcer. Improvement in pain levels will be associated with reduced need for oral analgesia, particularly opiates. Topical application of EMLA cream to the wound bed decreases healing time for chronic leg ulcers Improvement in leg ulcer pain and/or wound healing will be associated with gains in health-related quality of life. Hypothesis Our hypothesis is that the daily topical application of EMLA 5% cream to the wound bed of painful chronic leg ulcers as the primary dressing, will reduce wound-related pain and analgesic requirements, and improve the quality of life for patients with painful chronic leg ulcers. The secondary outcome measure is decreased wound healing times. As the primary outcome measure is pain reduction, this study will investigate painful chronic leg ulcers of varying aetiology, including venous, arterial and/or mixed ulceration.

  • A randomised controlled study comparing the effect of two different anticoagulation regimens on filter life during Continuous Renal Replacement Therapy (CRRT) – The Heparin Citrate (THC) Study

    The hypothesis that this trial will test is that the citrate/calcium approach for regional anticoagulation is more effective than the heparin/protamine method at maintaining functional filter life in patients receiving continuous renal replacement therapy (CRRT). CRRT is the form of dialysis that is used in the intensive care unit for critically ill patients. Blood is removed from the patients body and circulated through a membrane before being returned. This circuit outside the body causes the blood to start clotting unless a drug is used to prevent this happening. We will compare two different methods of preventing this clotting to see which one can prevent the blood clotting for the longer time. Prevention of blood clotting in the circuit is desirable because of the interruptions in treatment that this causes.

  • Can strength training change the strength, body shape and self esteem of overweight teenage boys?

    The primary purpose of this study is to determine whether participating in a 6-month strength training program can improve the strength, body shape and self-esteem of teenage boys. It is anticipated that at completion of the 6-month strength training program participants who took part in the intervention will show greater improvements in their self-esteem, strength and body shape relative to those participants who did not take part in the intervention.

  • 'A multi-centre phase II trial of early treatment intensification with R-ICE (rituximab – ifosfamide, carboplatin, etoposide) chemotherapy followed by BEAM ( BCNU(BCNU is Carmustine), etoposide, ara-C (ara-C is Cytarabine), melphalan) high dose chemotherapy and autologous stem cell transplantation for patients with poor prognosis diffuse large B-cell lymphoma

    This study looks at the effectiveness of early treatment intensification with R-ICE chemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) if positive PET/CT, or a further 2 cycles of R-CHOP-14 if negative PET/CT in patients with lymphoma which is classified as CD20 positive diffuse large B cell type who have received an initial 4 cycles of R-CHOP-14 chemotherapy. Who is it for? You can join this study if you: have lymphoma which is CD20 positive diffuse large B cell type (DLBCL) have either low intermediate, high intermediate, or high risk disease, or low risk disease with bulky tumour (> 7.5 cm) are considered fit and eligible for high dose chemotherapy(HDCT) and autologous stem cell transplantation (ASCT) have not received previous treatment for lymphoma. Trial details All participants will receive treatment with R-CHOP-14 chemotherapy every fourteen days over four cycles. They will then undergo PET/CT scanning. Participants who have scans that show the disease remains active will have their treatment intensified with R-ICE chemotherapy followed by HDCT with Z-BEAM (a special chemotherapy regimen) and ASCT. If the scans show that the cancer is no longer active, they will receive a further two cycles of the R-CHOP-14 chemotherapy. The study aims to monitor participants to see the effectiveness of this new treatment, particularly in relation to an expected increase in the number of patients who remain disease free after two years.

  • A randomised controlled study of high dose versus standard dose antibiotics for the prevention of bacterial sepsis in advanced liver disease

    Patients with advanced liver disease and ascites (intra-abdominal fluid) are at high risk of bacterial infections such as spontaneous bacterial peritonitis. Once daily antibiotics such as trimethoprim-sulfamethoxazole is considered standard treatment to prevent bacterial infections in this setting. However, breakthrough infections are still common. The study hypothesis is that a higher dose of antibiotics may be more effective in preventing bacterial infections in advanced liver disease. The purpose is therefore to conduct a trial to examine whether twice daily trimethoprim-sulfamethoxazole is more effective than the standard once daily dose at reducing bacterial infections and admissions to hospital in these high risk patients.

  • Kids - 'Go for your life': An initiative to support healthy eating and physical activity and reduce the risk of overweight and obesity in children

    The Kids - 'Go for your life' initiative aims to improve healthy eating and physical activity levels of children and in do so reduce the risk of overweight and obesity. To achieve this aim Kids - 'Go for your life' primarily works with primary schools and early childhood services, such as child care, family day care, and kindergartens, to support healthy eating and physical activity through and Award Program, using a health promoting schools approach. Schools and services join the program as member and receive a range of resources, training and support as they work through a number of crieteria to improve their policies and practices and reach award status. This Award program is supported within local communities by local government and community organisations.

  • How do interactions between oral and small intestinal exposure to oleic acid influence gastrointestinal function in healthy lean and obese participants

    To evaluate the hypotheses: (i) that both oral and small intestinal exposure to oleic acid (C18:1) will modulate antropyloroduodenal pressures, gut peptide, OEA and serum triglyceride responses, and suppress energy intake (ii) that combined oral and small intestinal exposure to oleic acid will interact to enhance the stimulation of antropyloroduodenal pressures, gut peptide, OEA and serum triglyceride responses, and suppression of energy intake, when compared with either oral or small intestinal infusion alone, and (iii) that these effects will occur in “tasters”, but not “non-tasters”, of oleic acid.

  • Pain relief after open radical prostate surgery: the use of a subcutaneous local anaesthetic solution.

    Postoperative pain relief for patients undergoing open radical prostatectomy (surgical removal of the prostate gland via a lower abdominal surgical incision) is provided by either strong painkillers such as intravenous morphine (delivered into the peripheral vein of the patient), or by the infusion of a local anaesthetic solution via an epidural catheter, which is inserted by an anesthetists into the epidural space that surrounds the spinal cord. The local anaesthetic solution acts by numbing the nerves around the spinal cord thereby providing pain relief from the surgical wound. One alternative method of administering the local anaesthetic solution for its beneficial effects without the inherent risks of epidural insertion is to administer the local anaesthetic solution directly into the patient’s circulation via a peripheral vein. Many well-designed studies investigating patients undergoing major abdominal surgery have shown that this method of administering the local anaesthetic solution provides excellent pain relief with minimal side effects. This technique also has beneficial effects on early postoperative return on bowel function. The administration of local anaesthetic solutions via this route is inexpensive, easy to administer, and safe. There is only one published clinical trial investigating this technique in patients undergoing radical prostatectomy. The main end point of this study was return of bowel function. However, it is not known if the addition of a systemic local anaesthetic solution with morphine accelerates postoperative recovery and shortens the duration of hospital stay. This research study will investigate this precise question. The purpose of the study is to compare whether the use of a lignocaine infusion together with intravenous morphine reduces time to readiness for discharge compared to using intravenous morphine alone. Adult patients undergoing elective open radical prostatectomy will be invited to participate. Patients will be approached and consented for surgery in the Urology or Anaesthetic Outpatient Clinics. All patients will have general anaesthesia and surgery performed accordance to the standard practice of their caring surgeons and anaesthetists. All patients will receive intravenous morphine together with simple pain relief adjuvants such as paracetamol and non-steroidal anti-inflammatory tablets. This is standard practice at Austin Hospital for all patients undergoing this operation. Consenting patients will be randomised into 2 groups. One group will receive an infusion of a local anaesthetic solution (ligonacaine); the other group will receive a placebo solution of normal saline. Neither the patient nor anaesthetist (or any member of the surgical or nursing team) will know which group the patient has been randomised to. This study is therefore a prospective double-blinded, randomised, placebo-controlled trial. This is the gold standard experimental research design. The main study aim will be to collect data from the patient’s postoperative records and assess when the patient is ready for hospital discharge. Other secondary end points collected will include pain and sedation scores, return of bowel function, cumulative morphine use, need for rescue pain medication and side effects of morphine and the local anaesthetic solution. Standard and specialised statistical tests will be used to analyse differences between the two groups of patients. All patients will be managed by the Austin Hospital acute pain service guidelines, in accordance with standard practices and infusion protocols.

  • A study investigating whether the administration of local anaesthetic solution via an interpleural catheter improves pain relief after liver resection surgery

    It is not known from published data how to best provide postoperative pain relief for patients who undergo major liver surgery. Many institutions that specialise in hepatobiliary surgery like Austin Health use intravenous morphine in addition to regional techniques such as an epidural or an interpleural catheter to provide postoperative analgesia. Research however shows that after patients undergo major liver surgery, there are significant disturbances in the clotting system of the body. This may increase the risk of bleeding complications. For this reason many institutions now consider epidural catheters to be unsafe in this setting because of the increased risk of epidural haematoma with the devastating neurological complication of spinal cord compression and paraplegia. At Austin Health, the standard accepted practice in providing postoperative analgesia after liver surgery is intravenous morphine, either alone or in combination with an interpleural catheter. An interpleural catheter is a small tube that is placed between the linings layers of the lungs by the anaesthetist at the end of the operation. A solution of local anaesthetic is infused continuously into the interpleural space, which then numbs the nerves that supply the skin over the surgical wound, reducing postoperative pain. Interpleural catheters have been shown to be effective in the management of pain following thoracic and upper abdominal surgery with minimal risks. However, no study has investigated whether the routine use of interpleural catheters after liver surgery is advantageous over morphine alone. The theoretical advantages of using an interpleural catheter is that it may result in less morphine being used, thereby reducing morphine related complications such as respiratory depression, sedation, nausea, vomiting and itch. However an interpleural catheter may not improve pain at all, therefore its use may be an unnecessary intervention that can be associated with uncommon complications such as infection, local anaesthetic toxicity and rarely a punctured lung. These questions have never been investigated in any scientific way before; therefore this study will help answer these questions and make a valuable contribution to caring for patients undergoing liver surgery. The purpose of this study is to compare whether the use of an interpleural catheter together with morphine provides better postoperative pain relief than just morphine alone. The provision of postoperative analgesia and the management of the patient in the postoperative period will not be changed or modified in any way as per the current postoperative guidelines and practices for analgesia after liver surgery. Patients undergoing suitable liver surgery will be invited to participate in the study. They will be approached after consenting for surgery in the hepatobiliary or anaesthetic outpatient clinics. All patients will have a general anaesthetic and surgery performed according to the usual practice of their caring clinicians. All patients will receive intravenous morphine together with simple analgesic adjuvants such as paracetamol. This is standard practice at Austin for all patients undergoing liver resection. Consenting patients will then be randomised into 2 groups. One group will receive an interpleural catheter with an infusion of local anaesthetic solution, the other group will not. Both techniques are considered standard practice at many centers that specialise in hepatobiliary surgery, including Austin Health. The main study aim will be to collect data from the patient’s postoperative records and assess there level of pain and how much morphine each group uses. These are standard parameters and observations routinely recorded in the patients records. We will use standard statistical tests to analyse the differences between the two groups of patients. The primary end-point will be pain on movement during the first 24 postoperative hours. Other end points will be cumulative 24 hour morphine consumption, with sufficient subjects being enrolled to find a 25% difference in morphine use between the two groups. Other end-points to be measured at 6, 12, 24 and 48 hours and will include patient rated scores for pain, nausea and itchiness, nurse-rated sedation score, and cumulative morphine doses. These are standard parameters and observations recorded for all patients. Subjects will be asked to rate their satisfaction with their postoperative analgesia on a qualitative scale at the completion of the trial. All patients will be managed by the Austin Health acute pain service guidelines, in accordance with standard practices for morphine and interpleural catheter based regimes.

  • A Case Series Investigating the efficacy of Rotation to Methadone in Palliative Patients with Cancer Related Pain

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